A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

April 10, 2009 updated by: Stanford University

A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma

The purpose of this study is to determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma and also to determine the safety of the combination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:- Able to comprehend and sign an IRB approved Informed consent

  • Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program.
  • Male or female 18 years or older
  • Willing to use contraception
  • Pathologic diagnosis of renal cell carcinoma
  • Bi-dimensionally measurable disease
  • Evidence of disease progression prior to start of treatment
  • Failed prior immunotherapy or unwilling/unable to receive prior immunotherapy
  • Adequate hematologic data: ANC.1.5; platelets>100x10^9
  • Adequate renal function: Creatinine clearance .50cc
  • Adequate liver function: Alkaline phos <3XULN AST/ALT <3XULN T.Bili <1.5XULN
  • ECOG performance status 0-1 Exclusion Criteria:- Known brain metastases.
  • Peripheral neuropathy.
  • Pregnant and/ or lactating female.
  • Unable to take a baby aspirin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.

Secondary Outcome Measures

Outcome Measure
Safety of the combination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Celgene Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimate)

September 27, 2005

Study Record Updates

Last Update Posted (Estimate)

April 14, 2009

Last Update Submitted That Met QC Criteria

April 10, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RENAL0001
  • NCT00226980

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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